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Acupuncture for Prophylaxis of Intrathecal Morphine Induced Itch in Elective Caesarean Delivery: a Randomized Controlled Double Blind Study

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Ramamoorthy KG et al./Journal of Acupuncture and Herbs 1 (2015)22-31

Acupuncture for Prophylaxis of Intrathecal Morphine Induced
Itch in Elective Caesarean Delivery: A Randomized Controlled
Double Blind Study
Karthik Ganesh Ramamoorthy FCARCSIa*, Mohammed Ibrahim MRCSb, Nasir Z.
Ahmad FRCS, MMScc, Kevin Bailey FFARCSIb, Paul O’ Connor. FFARCSIb
a.

Department of Anaesthesia, Fortis Malar Hospital, Chennai, India

b.

Department of Anaesthesia, Letterkenny General Hospital, Letterkenny, Ireland

c.

Department of Surgery,Letterkenny General Hospital, Letterkenny, Ireland

Received: August 3, 2015
Accepted: August 19, 2015

Abstract
Objective: The objective of this prospective randomised double blinded placebo controlled trial was to assess the efficacy of acupuncture for prophylaxis of intrathecal morphine induced pruritis in patients undergoing Elective
Caesarean delivery.
Methods: After ethical approval and informed consent parturients scheduled for elective Caesarean section under spinal anaesthesia with intrathecal morphine, were randomised to receive acupuncture (Group 1) or sham acupuncture (Group 2). In Group 1 acupuncture was applied unilaterally at the Quchi acupoint for 30 minutes before initiation of spinal anaesthesia. In Group 2 sham acupuncture was applied at a non – acupoint 2 cm lateral to Quchi for 30 minute before initiation of spinal anaesthesia. The primary outcome was the incidence of pruritis

and the secondary outcomes were severity of pruritis, patient’s satisfaction with anti-pruritic prophylaxis and the need for rescue anti-pruritic medications.
Results: The results showed statistically significant favour of acupuncture.

differences between acupuncture and sham acupuncture, in

There was significant difference in the incidence of pruritis ( 27 % vs 77%)

and VNRS

consistantly at 1 h, 4h, 8h and 24h between the groups.
Conclusion: Acupuncture at Quchi (LI 11) significantly reduces the incidence and severity of pruritis after subarachnoid opioids as a part of prophylactic multimodal approach.
Keywords: Acupuncture, Pruritis, Caesarean section, Quchi (LI11), Randomized double blinded clinical trial

Caesarean section is the most common surgery among

incidence of pruritis varies between 30% and 100%2.

women and spinal anaesthesia is the preferred choice

The exact mechanisms of neuraxial opioid-induced

of anaesthesia for majority of them. Intrathecal

pruritis remain unclear. Pruritis can be disturbing and

morphine is commonly used for pain relief for

often causes dissatisfaction in these parturient

Caesarean delivery and has been shown to be highly

especially in the postnatal period. Many drugs like

effective1. However it is associated with many side

antihistamines3,4, 5 HT3 receptor antagonists5,6, opioid

effects and the most common of these is pruritis. The

antagonists7, NSAIDS8, propofol9 have been used to prevent or treat this side effect, but have been only

*Corresponding author. Clinical doctor in the Department

marginally effective. The treatment of neuraxial

of Anaesthesia.

opioid-induced pruritis still remains a challenge.

E-mail address: dr.karthikganesh@gmail.com

Acupuncture (from Latin ‘acus’- ‘needle’ and

Hp: Helicobacter Pylori; EA: electro-acupuncture; IQR: interquartile range

Ramamoorthy KG et al./Journal of Acupuncture and Herbs1 (2015)22-31
‘pungere’ – ‘to prick’) has been used in China for

23

acupuncture.

thousands of years to treat pruritis. Some research has

On the morning of surgery patients were randomly

suggested that acupuncture at specific points is

allocated to one of the two treatment groups 'A' or 'B'

effective in preventing and treating

pruritis10,11,12.

Few

using centralised internet randomisation provided by

randomised controlled double blinded studies have

Sealed Envelope™.com. Randomisation was blocked

shown significant results on the prevention of pruritis

using random permuted blocks to ensure that the two

13,14.

groups are balanced periodically.
To the best of our knowledge, the efficacy of

The acupuncture point specifically selected in this

acupuncture for prophylaxis of intrathecal morphine

study is most important for treating pruritis as per a

induced pruritis in patients undergoing elective

standard Chinese acupuncture textbook 18. Quchi

Caesarean delivery has not been evaluated. Therefore

(`koo-chee`) meaning ‘crooked pond’ in Chinese is

we designed a randomised double blinded study to

the number 11 point on the Large Intestine (L.I.)

determine whether acupuncture can decrease the

meridian. Meridians are pathways around the body,

pruritis when combined with conventional measures

through which vital energy (known as 'Qi' or 'Chi')

to prevent pruritis. The primary objective of the study

flows to maintain normal body function. The Large

was to determine whether acupuncture would decrease

Intestine meridian starts at the forefinger (LI 1) and

the incidence of pruritis associated with intrathecal

travels through the throat to the nose (at LI 20). Quchi

morphine. Our null hypothesis was that there would

has a particular effect on the head and face (trigeminal

be no difference in the incidence of pruritis between

area) where the pruritis from intrathecal morphine is

acupuncture and sham acupuncture. The secondary

more pronounced, probably due to high concentration

objectives were to determine the difference in severity

of opioid receptors in the spinal nucleus of trigeminal

of pruritis, maternal satisfaction with anti-pruritic

nerve.

prophylaxis and need for rescue anti pruritic

The QuChi point has been used to treat conditions

medications.

such as hay fever, eczema and skin problems. It has

1 Methods

been shown that it can stimulate part of the immune

1.1 Participant

system and also is beneficial in reducing itching

The study was single centre, prospective, randomised,

symptoms in patients with kidney disease.

double blinded, parallel, placebo controlled and

1.3 Interventions

recruited ASA I – II parturient undergoing elective

1.3.1 Group ‘A’: Parturient in this group received

Caesarean delivery under spinal anaesthesia with

acupuncture at the point Quchi. Acupuncture was

intrathecal morphine for post operative analgesia.

performed in the antenatal ward by the first author

Exclusion criteria included patient refusal, ASA III –

who is qualified in acupuncture and had used

IV, pre existing pruritis, eczema, bleeding tendencies,

acupuncture in anaesthetic practice for about five

known allergy to any of the medications used in the

years. After prepping the skin with alcohol swab, a

study or any contraindications for spinal anaesthesia.

stainless steel acupuncture needle with guide tube was

1.2 Study design

inserted at Quchi (LI11) to a depth of approximately

Before patient enrolment the study protocol was

1- 2 cun (tsun; the width of a person's thumb at the

approved by the local institutional ethical committee.

knuckle) unilaterally. The needle was manually

Each parturient included in the study signed a written

stimulated by twisting for 2 minutes or until a DeQi

informed consent. The study was registered with

sensation (often described as variable feelings of

ClinicalTrails.gov (reg. no. NCT01283477) and we

tension, numbness, tingling and soreness reflecting

15,16,17

activation of muscle nerve afferents – A delta and

randomized,

possibly C fibres) was achieved was left in place for

followed the CONSORT and STRICTA 2010 recommendations controlled,

clinical

for trials reporting and interventions

in

30 minutes and then removed when the patients arrive

24

Ramamoorthy KG et al./Journal of Acupuncture and Herbs 1 (2015)22-31

at the theatre reception.

Table 1 Details of the acupuncture point and needling done for the study

Number of needle insertions
Point
Depth of insertion
Response sought
Needle stimulation
Needle retention time
Needle type
Number of treatment sessions

1 needle
LI11 Quchi unilateral
1- 2 cun de qi
Manual
30 minutes
Stainless steel 0.25 x 40 mm acupuncture needle with guide tube
Single

1.3.2 Group ‘B’: Parturient in this group received

Monitoring included continuous electrocardiogram,

‘penetrating sham’

acupuncture by the same

pulse oximetry, temperature and non invasive blood

acupuncturist similarly at non acupuncture point

pressure. Patients were co loaded with warmed

located 2 cm lateral to Quchi but not on any classic

compound

meridian. Because of close proximity of both points

administration

the patients, data collector and health care workers

anaesthesia was performed in sitting position with 27

involved were blinded.

G pencil point Whitacre spinal needle with introducer

17

sodium of lactate spinal 1000ml

during

anaesthesia.

Spinal

Placebos in acupuncture research most commonly

(Vygon Ltd.) at L3/4 intervertebral space and 0.5%

are non penetrating sham, penetrating sham or using

hyperbaric bupivicaine 10 mg (Marcain Heavy

telescopic placebo needles. In this study, penetrating

Steripack, AstraZeneca Ltd.) with fentanyl 20 mcg

sham acupuncture was used for placebo control group

(Janssen-Cilag Ltd.) and preservative free morphine

where in acupuncture needling is done at wrong point

150 mcg (Auden McKenzie Ltd.) was administered.

17

The patient was positioned with left lateral tilt and

.
The interventions were done with acupuncture

surgery was allowed to proceed once bilateral sensory

needles (32G x 1.5 inch / 0.25 mm x 40 mm) made of

block to ethyl chloride spray to T4 dermatome was

surgical grade stainless steel, EO gas sterilized,

confirmed. After the umbilical cord clamping,

disposable, packed singularly with guide tube and

oxytocin 5 units was given as a slow i.v. bolus

conformed to international standards (Mac, USA).

followed by an infusion if requested by the

A standard anatomical landmark was used for

obstetrician. Co-amoxiclav 1.2 g i.v. was administered

point locations. The acupuncture point used in group

as antibiotic prophylaxis. All patients received

‘A’ i.e. Quchi was located at the lateral end of elbow

granisetron 1mg i.v. as prophylaxis for PONV and

crease with the elbow flexed at 90 o midway between

pruritis. Paracetamol 2g i.v and diclofenac 100mg per

the biceps brachii tendon and the lateral epicondyle of

rectally were given as a part of multimodal analgesia.

humerus. The non acupuncture point used in group ‘B’

1.5 Post operative care

was located 2 cms lateral to Quchi.

Postoperative care was standard for both groups. All

1.4 Intra operative care

patients were monitored for 24 hr using dedicated

All patients included in the study underwent the same

postoperative observation sheet specific for patients

anaesthetic technique using a standardised protocol.

who

All were administered ranitidine 150mg orally on the

complications. Postoperative analgesia was given by

morning of the caesarean section, followed by 0.3%

paracetamol 1g orally every 6 h and sustained release

sodium citrate 30 ml 30 minutes before surgery.

diclofenac 75 mg orally every 12 h unless

have

received

intrathecal

morphine

for

Ramamoorthy KG et al./Journal of Acupuncture and Herbs1 (2015)22-31

contraindicated.

Patients

requiring

25

additional

(3)

moderate and

analgesia were given tramadol 50 mg orally as

(4)

severe.

required. No supplemental morphine was given within

A response of either none or mild was considered

12 hours unless all other analgesic measures have

successful anti-pruritic prophylaxis and a response of

failed. In the unlikely event that this is needed the

either moderate or severe was considered failed

anaesthetist was contacted. Pruritis was treated with

anti-pruritic prophylaxis.

chlorphenamine maleate 4 mg orally at patient’s

1.8 Rescue anti-pruritic medications

request.

Administration of rescue anti-pruritic medications if

1.6 Study parameters

administered was recorded from the drug prescription

The primary outcome measure of this study was the

card.

incidence of pruritis and the secondary outcomes

Baseline

data

including

demographic

included (1) severity of pruritis (2) patient’s

characteristics (age, race, body weight, height, body

satisfaction with anti-pruritic prophylaxis (3) need for

mass index, parity, ASA status) was also documented.

rescue anti-pruritic medications.

1.9 Statistical analysis

Patients were assessed by an investigator (M.I.)

Before the patients were enrolled in the trial, we

blinded to group allocation in the recovery room and

performed an initial power analysis to determine the

thereafter in the postnatal ward for the presence and

number of patients to be recruited. The percentages of

intensity of pruritis. Time of admission to recovery

patients that meet the primary outcome (i.e. incidence

room was taken as 0 hr and observations were made at

of pruritis) were based on the previous published

1 hr, 4 hr, 8 hr and 24 hr.

results 12,20. Based on these findings, it was

1.7 Incidence of Pruritis

calculated that 44 patients would be required to have a

Pruritis was defined as an uncomfortable sensation of

90% chance of detecting, as significant at the 5% level,

irritation of the skin that provokes the desire to scratch

a decrease in the primary outcome measure from 74%

or rub the affected site. An 11-point verbal numeric

in the control group to 30% in the experimental group.

rating scale (VNRS-11) with zero representing no itch

Allowing for 2% non-compliance, 24 patients are

and 10 representing the worst possible itch was used

required per group, making a total of 48 patients. Data

to assess the intensity of pruritis 19. The incidence of

analysis was done by an investigator (N.H.) blinded to

pruritis was defined as mean score > 1 over the first

group allocaion using SPSS v19.

24 hr.


2 Results

Severity of Pruritis

The severity of pruritis was assessed using

Fifty five patients were assessed for eligibility in the

following cut off points for the highest score 19

study. Forty nine were included as three of them did

recorded:

not meet the inclusion criteria like ASA > II and

(1) Mild pruritus:

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