MedPath

Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

Phase 4
Completed
Conditions
Pain
Interventions
Registration Number
NCT02790099
Lead Sponsor
Queen Mary Hospital, Hong Kong
Brief Summary

Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.

Detailed Description

The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.

Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.

Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.

On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.

Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
144
Inclusion Criteria
  • Planned for elective lower segment Caesarean section, using suprapubic transverse incision
  • Willing and able to participate after the study has been explained
  • Those understand either Cantonese, Putonghua or English
Exclusion Criteria
  • Patient with treatment for chronic pain
  • History of narcotic abuse/ recreational drug use
  • Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
  • Patient with pre-eclampsia

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Rectus sheath block onlyBupivacainePatient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia.
Intrathecal morphine groupMorphine0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block.
Both interventionBupivacainePatient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).
Both interventionMorphinePatient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).
Primary Outcome Measures
NameTimeMethod
Pain scoreat 12 hours postoperatively

Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

Secondary Outcome Measures
NameTimeMethod
Side effect3days postoperatively

side effects including itchiness, nausea/ vomiting, sedation

Requirement of oral analgesicswithin 24hours postoperatively

Paracetamol 1gram four times a day on request basis will be prescribed. The number of time requiring paracetamol will be recorded. The need of additional analgesics will be recorded.

Time of mobilization3days postoperatively

time of starting mobilization, defined as able to get out of bed without assistance

Pain score24hrs postoperatively

Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, Queen Mary Hospital

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Hong Kong, Hong Kong

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